Potential for biosimilars in rheumatology in Africa.

Biosimilars are products which are highly similar to a reference biologic product (RBP). In Africa, regulatory frameworks for biosimilar approval are still in development in many countries and few biosimilars for rheumatic diseases are currently available. The use of biosimilar medicines in Africa provides an important opportunity to treat more rheumatology patients with biologic drugs. This editorial aims to shed a light on the potential benefits, challenges and current efforts, regarding the use of biosimilars in Africa in Rheumatology.

Development and testing of a bespoke cultural intervention to support healthcare professionals with patients from a diverse background.

OBJECTIVE: Development and test of a culturally sensitive intervention for rheumatology healthcare professionals (HCPs). METHODS: Using a before and after study design, fifteen HCPs were recruited to undertake the bespoke intervention from four NHS sites across England, in areas serving a diverse population. The intervention was evaluated using the validated outcomes: [1] Patient Reported Physician Cultural Competency (PRPCC); and [2] Patient Enablement Instrument (PEI), measuring patients' perceptions of their overall healthcare delivery. Additionally, HCPs completed the Capability COM-B questionnaire (C), Opportunity (O) and Motivation (M) to perform Behaviour (B), measuring behaviour change. RESULTS: 200 patients were recruited before HCPs undertook the intervention (cohort 1), and 200 were recruited after (cohort 2) from fifteen HCPs, after exclusions 178 patients remained in cohort 1 and 186 in cohort 2. Patients identifying as White in both recruited cohorts were 60% compared with 29% and 33% of patients (cohorts 1 and 2 respectively) who identified as of South Asian origin. After the intervention, the COM-B scores indicated HCPs felt more skilled and equipped for consultations. No significant differences were noted in the average overall cultural competency score between the two cohorts in White patients (57.3 vs 56.8, p= 0.8), however, in the South Asian cohort, there was a statistically significant improvement in mean scores (64.1 vs 56.7, p= 0.014). Overall, the enablement score also showed a statistically significant improvement following intervention (7.3 vs 4.3, p< 0.001) in the White patients; and in the South Asian patients (8.0 vs 2.2, p< 0.001). CONCLUSION: This novel study provides evidence for improving cultural competency and patient enablement in rheumatology settings.

Patient educational needs and challenges in psoriatic arthritis.

PURPOSE OF REVIEW: To provide an overview of the recent research publications on educational needs of patients with psoriatic arthritis (PsA) and the associated challenges. RECENT FINDINGS: The rate of good treatment adherence in PsA can be as low as 57.7% and successful patient education can help improve treatment adherence. Also, 78.7% of patients who stopped their disease modifying anti-rheumatic drugs during the first wave of the COVID-19 pandemic did so without the advice of their clinician. In delivering educational needs, the aspects of disease process, treatment, self-help measures, managing pain, movement, psychological and social needs should all be addressed, whilst at the same time, recognising that PsA patients with multidomain disease, are likely to be dealing with more than just pain. Arthritis self-care management education is potentially beneficial, but up to 11% of educational YouTube videos may contain misleading patient opinion and many existing apps do not meet the needs of the patients with PsA. SUMMARY: Significant room for improvement exists in treatment adherence in PsA and patient education addressing the relevant educational needs could assist with this issue. However, patients should be advised to be wary of internet videos and other educational aids that were not created by health professionals.

The impact of COVID-19 on rheumatology practice across Africa.

OBJECTIVES: To identify the changes in rheumatology service delivery across the five regions of Africa from the impact of the COVID-19 pandemic. METHODS: The COVID-19 African Rheumatology Study Group created an online survey consisting of 40 questions relating to the current practices and experiences of rheumatologists across Africa. The CHERRIES checklist for reporting results of internet e-surveys was adhered to. RESULTS: A total of 554 completed responses were received from 20 countries, which include six in Northern Africa, six in West Africa, four in Southern Africa, three in East Africa and one in Central Africa. Consultant grade rheumatologists constituted 436 (78.7%) of respondents with a mean of 14.5 ± 10.3 years of experience. A total of 77 (13.9%) rheumatologists avoided starting a new biologic. Face-to-face clinics with the use of some personal protective equipment continued to be held in only 293 (52.9%) rheumatologists' practices. Teleconsultation modalities found usage as follows: telephone in 335 (60.5%), WhatsApp in 241 (43.5%), emails in 90 (16.3%) and video calls in 53 (9.6%). Physical examinations were mostly reduced in 295 (53.3%) or done with personal protective equipment in 128 (23.1%) practices. Only 316 (57.0%) reported that the national rheumatology society in their country had produced any recommendation around COVID-19 while only 73 (13.2%) confirmed the availability of a national rheumatology COVID-19 registry in their country. CONCLUSION: COVID-19 has shifted daily rheumatology practices across Africa to more virtual consultations and regional disparities are more apparent in the availability of local protocols and registries.

Can intersectionality help with understanding and tackling health inequalities? Perspectives of professional stakeholders.

BACKGROUND: The concept of "intersectionality" is increasingly employed within public health arenas, particularly in North America, and is often heralded as offering great potential to advance health inequalities research and action. Given persistently poor progress towards tackling health inequalities, and recent calls to reframe this agenda in the United Kingdom and Europe, the possible contribution of intersectionality deserves attention. Yet, no existing research has examined professional stakeholder understandings and perspectives on applying intersectionality to this field. METHODS: In this paper we seek to address that gap, drawing upon a consultation survey and face-to-face workshop (n = 23) undertaken in the United Kingdom. The survey included both researchers (n = 53) and policy and practice professionals (n = 20) with varied roles and levels of engagement in research and evaluation. Topics included familiarity with the term and concept "intersectionality", relevance to health inequalities work, and issues shaping its uptake. Respondents were also asked to comment on two specific policy suggestions: intersectionally targeting and tailoring interventions, and evaluating the intersectional effects of policies. The workshop aims were to share examples of applying intersectionality within health inequalities research and practice; understand the views of research and practice colleagues on potential contributions and challenges; and identify potential ways to promote intersectional approaches. RESULTS: Findings indicated a generally positive response to the concept and a cautiously optimistic assessment that intersectional approaches could be valuable. However, opinions were mixed and various challenges were raised, especially around whether intersectionality research is necessarily critical and transformative and, accordingly, how it should be operationalized methodologically. Nonetheless, there was general agreement that intersectionality is concerned with diverse inequalities and the systems of power that shape them. CONCLUSIONS: We position intersectionality within the wider context of health inequalities policy and practice, suggesting potential ways forward for the approach in the context of the United Kingdom. The views of policy and practice professionals suggest that intersectionality has far to travel to help counter individualistic narratives and to encourage an approach that is sensitive to subgroup inequalities and the processes that generate them. Examples of promising practice, albeit mostly in North America, suggest that it is possible for intersectionality to gain traction.

Unique role of rheumatology in establishing collaborative relationships in research. Past, present and future of patient engagement.

The specialty of rheumatology takes care of people with disabling and long-term musculoskeletal conditions. For these patients, good healthcare requires the establishment of a sustainable partnership with healthcare professionals. For over two decades, rheumatology has been a frontrunner in piloting and implementing new kinds of partnerships in scientific research. In this viewpoint paper, we provide evidence for the leading role of rheumatology in developing strategies for engaging patients in research agenda setting, outcome research, developing treatment recommendations, assessing grant applications, conducting patient-centred research and transferring knowledge from research into practice. Experiences and lessons learnt in rheumatology are regularly published and are currently widely adapted and implemented in other specialties and research contexts. Challenges still exist and it is expected that rheumatology, as a leading discipline in this field, may further enhance our knowledge, expertise and understanding of the conditions for relational empowerment and meaningful patient involvement.

Musculoskeletal manifestations of Ebola virus.

The 2014 West African Ebola virus disease outbreak shocked the world as it swept through the region leaving Guinea, Liberia and Sierra Leone struggling to gain control. As the largest Ebola virus disease outbreak to date, there are more survivors in its wake than ever before, with a spectrum of health problems requiring management. Here we review various musculoskeletal manifestations of the virus that can occur both during and after the infection, and consider possible pathogenesis.

Vasculitis in Africa.

PURPOSE OF REVIEW: Systemic vasculitides are characterized by inflammation of blood vessel walls leading to a myriad of organ disorders depending on the size, site, and location of the affected blood vessel. The epidemiology of vasculitis in the developing world has been inadequately documented. The description of the vasculitides in Africa, both from hospital series as well as taking into consideration, previous epidemiological studies in the community, indicates that these conditions have been rare until relatively recently. In view of these past observations, this review of publications on the topic looks to shed light on the current state of vasculitis in Africa. RECENT FINDINGS: Takayasu and Kawasaki appear to be the most commonly reported vasculitides in Africa. Most of the published reports are from North and South Africa. Furthermore, the contribution of vasculitis associated with infections, and in particular HIV, is significant. There are increasing numbers of publications reflecting a growing recognition of the vasculitides in Africa.

Patients and nursing staff views of using the education needs assessment tool in rheumatology clinics: a qualitative study.

AIMS AND OBJECTIVES: To evaluate the usability of the educational needs assessment tool in clinical practice, from a practitioner and patient perspective and to establish whether patients perceive that they are getting an equally good or equally inadequate education service for their needs. BACKGROUND: The educational needs assessment tool was developed to enable patients with Rheumatoid Arthritis to assess their education needs prior to a consultation with a health professional. The educational needs assessment tool has been translated into nine languages and measurement properties have been established, however, its usability in clinical practice has not been studied. DESIGN: A qualitative study embedded into a multicentre RCT in which patients had been randomised into either educational needs assessment tool-focused education (Experimental Group) or usual care (control group). METHODS: Both groups were seen by a clinical nurse specialist. Sixteen patients and four clinical nurse specialists were recruited from the Rheumatology Outpatient Departments of three Acute Hospitals within the U K. Data were collected by interviews with patients and clinical nurse specialist. Analysis followed the Framework approach. RESULTS: Patients and clinical nurse specialist found completion of the educational needs assessment tool straightforward, comprehensive and easy to use. Completing the educational needs assessment tool helped patients to focus on what they needed to know from the clinical nurse specialist. Patients in both the control group and the experimental group felt supported and reassured by their clinical nurse specialist and perceived that they received a good and adequate education provision. CONCLUSION: This study provides useful insights into the ability of the educational needs assessment tool to assess the educational needs of patients with rheumatoid arthritis in routine clinical practice. RELEVANCE TO CLINICAL PRACTICE: The educational needs assessment tool would be useful as a structured guide for nurses when assessing and meeting individual patient educational needs. This has the potential to improve patient-centred care, involve patients more actively in their care and enhance the long-term effects of patient education provision.

Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor.

OBJECTIVES: Apremilast, an oral phosphodiesterase 4 inhibitor, regulates inflammatory mediators. Psoriatic Arthritis Long-term Assessment of Clinical Efficacy 1 (PALACE 1) compared apremilast with placebo in patients with active psoriatic arthritis despite prior traditional disease-modifying antirheumatic drug (DMARD) and/or biologic therapy. METHODS: In the 24-week, placebo-controlled phase of PALACE 1, patients (N=504) were randomised (1:1:1) to placebo, apremilast 20 mg twice a day (BID) or apremilast 30 mg BID. At week 16, patients without ≥20% reduction in swollen and tender joint counts were required to be re-randomised equally to either apremilast dose if initially randomised to placebo or remained on their initial apremilast dose. Patients on background concurrent DMARDs continued stable doses (methotrexate, leflunomide and/or sulfasalazine). Primary outcome was the proportion of patients achieving 20% improvement in modified American College of Rheumatology response criteria (ACR20) at week 16. RESULTS: At week 16, significantly more apremilast 20 mg BID (31%) and 30 mg BID (40%) patients achieved ACR20 versus placebo (19%) (p<0.001). Significant improvements in key secondary measures (physical function, psoriasis) were evident with both apremilast doses versus placebo. Across outcome measures, the 30-mg group generally had higher and more consistent response rates, although statistical comparison was not conducted. The most common adverse events were gastrointestinal and generally occurred early, were self-limiting and infrequently led to discontinuation. No imbalance in major adverse cardiac events, serious or opportunistic infections, malignancies or laboratory abnormalities was observed. CONCLUSIONS: Apremilast was effective in the treatment of psoriatic arthritis, improving signs and symptoms and physical function. Apremilast demonstrated an acceptable safety profile and was generally well tolerated. CLINICAL TRIAL REGISTRATION NUMBER: NCT01172938.

Embracing unity at OMERACT: Valuing equity, promoting diversity, fostering inclusivity.

OBJECTIVE: To increase awareness and understanding of the principles of Equity, Diversity, and Inclusivity (EDI) within Outcome Measures in Rheumatology's (OMERACT) members. For this, we aimed to obtain ideas on how to promote and foster these principles within the organization and determine the diversity of the current membership in order to focus future efforts. METHODS: We held a plenary workshop session at OMERACT 2023 with roundtable discussions on barriers and solutions to increased diversity within OMERACT. We conducted an anonymous, web-based survey of members to record characteristics including population group, gender identity, education level, age, and ability. RESULTS: The workshop generated ideas to increase diversity of participants across the themes of building relationships [12 topics], materials and methods [5 topics], and conference-specific [6 topics]. Four hundred and seven people responded to the survey (25 % response rate). The majority of respondents were White (75 %), female (61 %), university-educated (94 %), Christian (42 %), spoke English at home (60 %), aged 35 to 55 years (50 %), and did not report a disability (64 %). CONCLUSION: OMERACT is committed to improving its diversity. Next steps include strategic recruitment of members to the EDI working group, drafting an EDI mission statement centering equity and inclusivity in the organization, and developing guidance for the OMERACT Handbook to help all working groups create actionable plans for promoting EDI principles.

OMERACT Core outcome measurement set for shared decision making in rheumatic and musculoskeletal conditions: a scoping review to identify candidate instruments.

OBJECTIVES: Shared decision making (SDM) is a central tenet in rheumatic and musculoskeletal care. The lack of standardization regarding SDM instruments and outcomes in clinical trials threatens the comparative effectiveness of interventions. The Outcome Measures in Rheumatology (OMERACT) SDM Working Group is developing a Core Outcome Set for trials of SDM interventions in rheumatology and musculoskeletal health. The working group reached consensus on a Core Outcome Domain Set in 2020. The next step is to develop a Core Outcome Measurement Set through the OMERACT Filter 2.2. METHODS: We conducted a scoping review (PRISMA-ScR) to identify candidate instruments for the OMERACT Filter 2.2 We systematically reviewed five databases (Ovid MEDLINE®, Embase, Cochrane Library, CINAHL and Web of Science). An information specialist designed search strategies to identify all measurement instruments used in SDM studies in adults or children living with rheumatic or musculoskeletal diseases or their important others. Paired reviewers independently screened titles, abstracts, and full text articles. We extracted characteristics of all candidate instruments (e.g., measured construct, measurement properties). We classified candidate instruments and summarized evidence gaps with an adapted version of the Summary of Measurement Properties (SOMP) table. RESULTS: We found 14,464 citations, read 239 full text articles, and included 99 eligible studies. We identified 220 potential candidate instruments. The five most used measurement instruments were the Decisional Conflict Scale (traditional and low literacy versions) (n=38), the Hip/Knee-Decision Quality Instrument (n=20), the Decision Regret Scale (n=9), the Preparation for Decision Making Scale (n=8), and the CollaboRATE (n=8). Only 44 candidate instruments (20%) had any measurement properties reported by the included studies. Of these instruments, only 57% matched with at least one of the 7-criteria adapted SOMP table. CONCLUSION: We identified 220 candidate instruments used in the SDM literature amongst people with rheumatic and musculoskeletal diseases. Our classification of instruments showed evidence gaps and inconsistent reporting of measurement properties. The next steps for the OMERACT SDM Working Group are to match candidate instruments with Core Domains, assess feasibility and review validation studies of measurement instruments in rheumatic diseases or other conditions. Development and validation of new instruments may be required for some Core Domains.

Consensus on the definitions and descriptions of the domains of the OMERACT Core Outcome Set for shared decision making interventions in rheumatology trials.

OBJECTIVE: To gain consensus on the definitions and descriptions of the domains of the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials evaluating shared decision making (SDM) interventions. METHODS: Following the OMERACT Handbook methods, our Working Group (WG), comprised of 90 members, including 17 patient research partners (PRPs) and 73 clinicians and researchers, had six virtual meetings in addition to email exchanges to develop draft definitions and descriptions. The WG then conducted an international survey of its members to gain consensus on the definitions and descriptions. Finally, the WG members had virtual meetings and e-mail exchanges to review survey results and finalize names, definitions and descriptions of the domains. RESULTS: WG members contributed to developing the definitions. Fifty-two members representing four continents and 13 countries completed the survey, including 15 PRPs, 33 clinicians and 37 researchers. PRPs and clinicians/researchers agreed with all definitions and descriptions with agreements ranging from 87% to 100%. Respondents suggested wording changes to the names, definitions and descriptions to better reflect the domains. Discussions led to further simplification and clarification to address common questions/concerns about the domains. CONCLUSION: Our WG reached consensus on the definitions and descriptions of the domains of the core domain set for rheumatology trials of SDM interventions. This step is crucial to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set. CLINICAL SIGNIFICANCE: The current study provides consensus-based definitions and descriptions for the domains of the OMERACT core domain set for shared decision making interventions from patients/caregivers, clinicians and researchers. This is a crucial step to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set for trials of SDM interventions.

Patient and public involvement in rheumatic and musculoskeletal research: an idea whose time has firmly come.

Patient and public involvement is an idea whose time has firmly come. It is the views of these Guest Editors that it is the right thing to do morally and improves research quality and applicability.

Management of Dactylitis in Patients With Psoriatic Arthritis: An Updated Literature Review Informing the 2021 GRAPPA Treatment Recommendations.

OBJECTIVE: This literature review aimed to identify the most efficacious current interventions for dactylitis and provide up-to-date scientific evidence to support the 2021 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) recommendations on the management of psoriatic arthritis. METHODS: Original articles published from 2013 to 2020, registered in MEDLINE, Embase, and Cochrane Library, describing interventional trials and reporting dactylitis-related outcomes were included. The 20 members of the GRAPPA dactylitis group were divided into 9 subgroups according to treatment, and members of each group independently extracted data from articles/abstracts corresponding to their group by using a standardized data extraction form. RESULTS: Forty-nine publications were analyzed, representing 40 randomized clinical trials (RCTs) and including 16,752 patients. Dactylitis was assessed as a secondary outcome in 97.5% of these trials and more than 40% of RCTs did not employ a specific dactylitis measure or instrument. CONCLUSION: The emergence of agents with novel mechanisms of action in recent years, such as interleukin 17 (IL-17), IL-12/23, IL-23, and Janus kinase inhibitors, has significantly expanded the available treatment options for dactylitis. This article points out the lack of consensus regarding dactylitis assessment and the paucity of data concerning the effect of local steroid injections, nonsteroidal antiinflammatory drugs, and conventional disease-modifying antirheumatic drugs. Clinical trials evaluating the effect of these traditional and low-cost medications used to treat dactylitis should be encouraged.

Proceedings of the GRAPPA 2022 Executive Retreat.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) leadership congregated for a strategic planning meeting before the 2022 GRAPPA annual meeting in New York, USA. Meeting aims were to review GRAPPA's performance in relation to its 2016 goals and identify successes and areas for further improvement, identify key GRAPPA priorities and activities for the next 5 years, and explore committee structures to best support these aims.

Evaluating upadacitinib for the treatment of psoriatic arthritis.

INTRODUCTION: Psoriatic arthritis is an extra-cutaneous manifestation affecting up to 40% of psoriasis patients with multiple therapies recommended by international guidelines including conventional and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs) as well as biologics. Janus kinase inhibitors (JAKis) have emerged as a unique therapeutic target with tofacitinib the first to gain FDA approval in 2017. The non-selectivity of older JAKis increases the risk of off-target effects such as suppression of hemopoiesis hence the rationale for more selective alternatives. AREAS COVERED: This paper explores the use of upadacitinib (a selective JAK1 inhibitor) for the treatment of psoriatic arthritis. It covers its chemical properties, pharmacokinetics, pharmacodynamics, efficacy, safety and regulation. EXPERT OPINION: In our opinion, upadacitinib is set to play an important role in the treatment of psoriatic arthritis as demonstrated by the SELECT-PsA trials especially in patients with poor or non-response to current first-line therapies. It's JAK1 receptor selectivity promises a lower side effect profile compared to the older nonselective JAKis but this will require confirmation with long-term clinical trial data.